CloSYS Fluoride Toothpaste

Manufacturer
Rowpar Pharmaceuticals, Inc.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:52:49

Label at a glance#

ProductCloSYS
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. children under 6 years of age: instruct in good brushing and rinsing habits (to minimize swallowing). supervise children as necessary until capable of using without supervision. do not swallow children under 2 years of age: consult a dentist or doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.13% w/v fluoride ion)

PURPOSE:

OTC - PURPOSE SECTION

Anticavity

USE:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

children under 6 years of age:

  • instruct in good brushing and rinsing habits (to minimize swallowing).
  • supervise children as necessary until capable of using without supervision.
  • do not swallow

children under 2 years of age:

consult a dentist or doctor

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

water, hydrated silica, stabilized chlorine dioxide, sarkosyl (coconut derived), disodium hydrogen phosphate, cellulose gum, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sucralose, menthol crystals

SPL UNCLASSIFIED SECTION

Use of stabilized chlorine dioxide is protected under U.S. & foregin patents-see CloSYS.com/patents

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-643-3337

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Closys®
Anticavity Fluoride Toothpaste

SULFATE-FREE

NEW LOOK!

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS ®
Anticavity Fluoride Toothpaste

SENSITIVE
TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING
SULFATE-FREE

HELPS REBUILD WEAKEND
TOOTH ENAMEL

Protects Against
Cavities

Freshens Breath

Non-Irritating
Formula

Gentle Mint

7oz (196g)

NON-IRRITATING
SULFATE-FREE

pH balanced

Fights
Cavities

Strengthens
Enamel

Closys®
Anticavity Fluoride Toothpaste

SENSITIVE TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING SULFATE-FREE

HELPS REBUILD WEAKEND TOOTH ENAMEL

Protects Against Cavities

Freshens Breath

Non-Irritating Formula

Gentle Mint 7oz (196g)

7 carton
7 carton

Closys®
Anticavity Fluoride Toothpaste

SULFATE-FREE

NEW LOOK!

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS ®
Anticavity Fluoride Toothpaste

SENSITIVE
TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING
SULFATE-FREE

HELPS REBUILD WEAKEND
TOOTH ENAMEL

Protects Against
Cavities

Freshens Breath

Non-Irritating
Formula

Gentle Mint

3.4oz (96g)

NON-IRRITATING
SULFATE-FREE

pH balanced

Fights
Cavities

Strengthens
Enamel

Closys®
Anticavity Fluoride Toothpaste

SENSITIVE TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING SULFATE-FREE

HELPS REBUILD WEAKEND TOOTH ENAMEL

Protects Against Cavities

Freshens Breath

Non-Irritating Formula

Gentle Mint 3.4oz (96g)

3.4 carton
3.4 carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN11
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD11
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY11
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY11
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58578-0749-1CloSYS1 in 1 BOXPASTE, DENTIFRICE111
58578-0749-1CloSYS96 g in 1 TUBEPASTE, DENTIFRICE9611
58578-0749-2CloSYS1 in 1 BOXPASTE, DENTIFRICE111
58578-0749-2CloSYS198 g in 1 TUBEPASTE, DENTIFRICE19811
58578-0749-3CloSYS21 g in 1 TUBEPASTE, DENTIFRICE2111
58578-0749-3CloSYS1 in 1 BOXPASTE, DENTIFRICE111
58578-0749-4CloSYS198 g in 1 TUBEPASTE, DENTIFRICE19811
58578-0749-4CloSYS2 in 1 PACKAGEPASTE, DENTIFRICE211

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58578-074958578-0749-1, 58578-0749-2, 58578-0749-3, 58578-0749-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.5f87abb7-0e9d-6369-e053-2a91aa0a24112026-03-31WarningsExact identifier
ndc (package): 58578-0749-2
ndc (package): 58578-0749-4
ndc (package): 58578-0749-3
ndc (package): 58578-0749-1
ndc (product): 58578-0749
ndc11 (package): 58578074901
ndc11 (package): 58578074903
ndc11 (package): 58578074902
ndc11 (package): 58578074904
spl id: 4aab2169-2fe1-4d9b-94a0-45724392e6bc
spl set id: 5f87abb7-0e9d-6369-e053-2a91aa0a2411

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.